Roche discontinues development of new diabetes drug

Roche, the Swiss pharmaceutical giant, has discontinued development of a potentially important diabetes drug, a move that could raise safety questions about the entire category of drugs, which includes the controversial medicine Avandia.

Roche said Wednesday that an independent safety monitoring committee had recently recommended halting a latestage clinical trial of the drug, aleglitazar, because of “safety signals and lack of efficacy.” The company said that it had decided to halt that study and all others involving the drug.

“We are very disappointed,” Dr. A. Michael Lincoff, study chairman, said. A spokesman for the company, which is based in Basel, Switzerland, said the drug had caused an increase in fractures, kidney problems and heart failure in the trial.

Aleglitazar was designed to treat cardiovascular risk factors like cholesterol as well as diabetes. In a bold move, Roche was testing the drug not for its ability to lower blood sugar, the usual yardstick for a diabetes drug, but to see if it could prevent heart attacks and strokes in people with Type 2 diabetes.

A successful test would have been considered a major advancement against diabetes because better control of blood sugar has not generally been shown to lower the risk of heart attacks and strokes.

Many other companies abandoned efforts to develop similar drugs years ago after safety problems.

The failure of aleglitazar could influence the federal Food and Drug Administration’s deliberations over GlaxoSmithKline’s diabetes drug Avandia, which works similarly. Avandia was severely restricted in the United States and bannedin Europe in 2010 because of fear it could raise the risk of heart attacks and strokes. But an advisory panel to the FDA recommended last month that the restrictions be eased. The agency has yet to decide.

Critics of Avandia could cite the setback to Roche’s drug to argue for keeping the restrictions.

“I think it shows that the class of drugs has significant problems with toxicity, particularly cardiovascular toxicity,” Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and a leading critic of Avandia, said Wednesday.

The setback is the latest in Roche’s effort to diversify beyond its mainstay business of cancer drugs. Most of those drugs, including the blockbusters Avastin, Herceptin and Rituxan, were developed by Genentech, its California biotechnology subsidiary.

Business, Pages 64 on 07/14/2013

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